Pharmacovigilance is defined by the international agencies and regulators as the process and science that studies drug safety, namely the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.
As we have seen, the assessment of drug safety during a clinical trial gives an account of the adverse events reported during the study period. Although this appears quite straightforward, there are several nuances regarding who is collecting the adverse events (clinician or patient), what counts as an adverse event and how serious it is, distinguishing between expected and unexpected adverse events, and so on.
In our world today, we want drugs to be effective, but most importantly, we want them to be safe. Consequently, drug safety is assessed during all phases of a clinical trial and beyond, well after the introduction of a given drug in the market. Pharmacovigilance aims at improving patient care and patient safety when using medicines throughout the product’s life cycle.
Pharmacovigilance LS Academy courses deal with the latest news on the evaluation and prevention of adverse events or other drug-related events, to ensure a good benefit/risk profile for patients: regulations in place, strategy, methodology, and even the use of artificial intelligence for pharmacovigilance.
These trainings are designed for clinical research professionals who wish to know more about Pharmacovigilance or for those already in the field who need high-level training.
Our courses in Pharmacovigilance are held as interactive workshops, with lectures, discussions, and exercises.